05 January 2012

FDA: E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide - Update

The ICH Implementation Guide has been further updated to provide sufficient information to readers, and the draft E2B(R3) implementation guidance is now available for public comment [link to NOA]. There are significant differences between the data models for E2B (R2) and E2B(R3), and a draft backwards and forwards compatibility (BFC) document has been produced that defines the compatibility of data elements between the two versions of the specification. Comments are also invited on this document.

To find updated guidance use the below mentioned weblink

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